This job is currently Archived,
Posted on : 20 February 2017
Jazz Pharmaceuticals is seeking a clinical development physician to join the Life Cycle Management Clinical Development team in the Sleep Therapeutic Area. You will be responsible for generating global (US and Ex US) clinical development plans and protocols to support new indications, medical monitoring of trials, the oversight and interpretation of clinical trials data, clinical interactions with investigators and multidisciplinary groups across the company including R&D, commercial, regulatory and business developmentJob Responsibilities:Serve as clinical leader on trials that have the potential to expand the indications for molecules currently in development as well as for commercialized products.Develop and implement strategic clinical plans in alignment with LCM goals for the Sleep TA .Identify and interact with opinion leaders to integrate current clinical practice and guidelines into global clinical development plans including relevant industry developmentsWork with project team members, regulatory affairs and senior management to integrate competitive intelligence and regulatory strategy with the clinical strategic plan.Develop phase II -IV clinical protocols and work closely with other functional areas within the R&D Departments (regulatory, clinical operations, data management, biostatistics, clinical pharmacology, preclinical) to facilitate the execution of clinical trials and programsProvide clinical input to Statistical Analysis Plan and assume responsibility for the clinical review and interpretation of the clinical trial data.Lead preparation of clinical portions of all relevant regulatory filings (IND, NDA, etc) and review sections from other functional areasDevelop strategy for and lead clinical advisory board meetings to obtain strategic input into clinical development programsLead preparation of clinical portions of all relevant regulatory filings (IND, NDA, etc) and review sections from other functional areasDevelop strategy for and lead clinical advisory board meetings to obtain strategic input into clinical program developmentServe as clinical (and medical) resource for clinical issues raised by internal and external collaborators, investigators, consultants and business development and investor contactsServe as lead clinical (and or medical) representative with regulatory agenciesProvide strategic input on new product concepts, long-range strategic plans and licensing opportunitiesProvide leadership in collaborations with strategic partners.Supervise and be accountable for the generation of and management of messaging in clinical program and regulatory submissionsAccountable for success and implementation of the clinical development strategyRepresent the company at scientific, industry, regulatory, advocacy and financial community meetings and presentations, as well as other public relations opportunities.Monitor clinical trials for safetyWork in conjunction with Drug Safety and Pharmacovigilance to insure timely reporting of safety signals to regulatory authorities This person will provide leadership and lead and manage Clinical Scientists as the team grows.ESSENTIAL QUALIFICATIONS:MD, DO degree – psychiatrist, neurologist, sleep specialist, preferred but other physicians will be considered, particularly those with expertise in clinical development in neurology, sleep or psychiatry; U.S. Board Certification/Eligibility preferred10 years of clinical development experience. Demonstrated scientific and therapeutic expertiseExcellent written and verbal communications skills and ability to work in a collaborative team environmentPREFERRED REQUIREMENTS:Experience with IND and NDA submissions preferredExperience interacting with regulators and business partners preferredCollaborative and flexible in personal interactions at all levels of the companyAbility to work proactively and effectively, with exceptional creative problem solving skillsProven strategic planning and communication skills across multiple disciplinesDemonstrated ability to work with senior management and provide input toward the setting and execution of corporate and departmental objectivesThere is some travel required. Over short periods of time, it can be up to 50%.Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any characteristic protected by law.
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